BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 200

    MDR report key: 1040277 · Received May 8, 2008

    Report

    Report Number
    2028159-2008-00161
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 10, 2008
    Report Date
    April 7, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEPARTMENT OF OPHTHALMOLOGY'S REPORT FOR "POSTOPERATIVE ENDOPHTHALMITIS, A GUIDE TO DIAGNOSIS & TREATMENT," AND QUESTIONS TO DETERMINE IF CLEANING AND DIRECTIONS FOR USE INFO WERE ADDRESSED WITH THE FACILITY, BUT NO RESPONSE WAS NOTED. THE SURGEON SUSPECTS OTHER INSTRUMENTS IN THE OCCURRENCE OF THESE INFECTIONS. THE ROOT CAUSE OF THE REPORTED CASE OF ENDOPHTHALMITIS CANNOT BE DETERMINED IN THIS INVESTIGATION. THERE IS ONE ADDITIONAL COMPLAINT RELATED TO THE REPORTED EVENT FROM THE SAME FACILITY, AND THE SAME CONSOLE, BUT A DIFFERENT PT. A REVIEW OF COMPLAINT TREND INDICATES NO ADVERSE TRENDS FOR THE REPORTED COMPLAINT. ADDITIONAL INFO RECEIVED STATED THE SYSTEM IS STILL USED WITHOUT PROBLEM. NO OTHER CASE OF ENDOPHTHALMITIS HAS BEEN REPORTED. ALL THE FACILITY'S PROCEDURES REGARDING THE CLEANING AND THE STERILIZATION HAVE BEEN REVIEWED BUT NOTHING WAS FOUND OUT OF COMPLIANCE. THIS REPORT MAILED IN TO FDA ON: 05/07/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, TWO CASES OF ENDOPHTHALMITIS. THIS PT WAS DIAGNOSED ONE MONTH POST-OP. THE PT WAS SEEN IN 2008 AND THERE WAS VISUAL DISCOMFORT DUE TO THE DEPOSITS, ALTHOUGH THE SURGEON WAS OPTIMISTIC ABOUT THE VISUAL RECOVERY ALREADY SEEN. THE SURGEON COMPLETED A DOUBLE DISINFECTION WITH BETADINE (PROVIDONE-IODINE) ON THE EYE, EYELIDS AND FORNIX FOR TWO (2) TO THREE (3) MINUTES PRIOR TO SURGERY. DURING THE INITIAL SURGERY, A 3.2 MM TEMPORAL INCISION WAS COMPLETED. THE INCISION WAS SUTURED WITH ONE STITCH. THERE WERE GREY INFLAMMATORY DEPOSITS ON THE INTRAOCULAR LENS (IOL) NOTED AND ANTIBIOTICS WERE GIVEN. THE PT WAS UNDER GENERAL ANESTHESIA, SO THE PT HAD TO BE DECONTAMINATED TWICE, FIRST BY THE ANESTHETIST AND SECONDLY BY THE SURGEON. NO ISSUE OCCURRED DURING SURGERY. ADDITIONAL INFO REC'D STATED, THE PT REQUIRED UNPLANNED INTRAVENOUS ANTIBIOTHERAPY, INTRAVITREOUS INJECTION OF ANTIBIOTICS AND CORTICOIDS (SIC) AND LOCAL TREATMENT WITH ANTIBIOTICS, MYDRIATIC AND AN ANTI-INFLAMMATORY TO ADDRESS THE REPORTED EVENT. BACTERIOLOGIC CULTURE WAS DONE TO THE AQUEOUS SAMPLE AND THE RESULTS WERE NEGATIVE. THE BALANCED SALT SOLUTION, WITH EPINEPHRINE, WAS CHANGED BETWEEN PROCEDURES, ALONG WITH THE IRRIGATION/ASPIRATION TIPS. THE CUSTOM PACK, IOL, AND VISCOELASTICS (TWINVISC) USED BY THE SURGEON WERE NOT ALCON PRODUCTS. THE PT OUTCOME WAS NOTED AS GOOD. ADDITIONAL INFO REC'D STATED THE PT TOTALLY RECOVERED WITHOUT SEQUELAE. THIS REPORT IS FOR ONE PT; FOR ADDITIONAL PT SEE MFG. REPORT # 2028159-2008-00160.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 200 OPHTHALMIC SURGERY SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention CUSTOM PACK| VISCOELASTICS| IOL| BSS WITH EPI